NCT06129864PHASE3RECRUITING

A Global Study of Volrustomig (MEDI5752) for Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma Following Definitive Concurrent Chemoradiotherapy

A Phase III, Randomized, Open-Label, Multi-Center, Global Study of Volrustomig (MEDI5752) as Sequential Therapy Versus Observation in Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma, Who Have Not Progressed Following Definitive Concurrent Chemoradiotherapy (eVOLVE-HNSCC)

Sponsor: AstraZeneca

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

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Key Facts

Study type

INTERVENTIONAL

Conditions

Locally Advanced Head and Neck Squamous Cell Carcinoma

Interventions

volrustomig

Enrollment

1,145 participants

Primary completion

Apr 2028

Study completion

Sep 2030

First posted

Nov 2023

Last updated

May 2026

Primary Endpoints (CT.gov)

Progression-Free Survival (PFS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors

Time frame: Up to approximately 8 years

Secondary Endpoints

Progression-Free Survival (PFS) in the unresected LA-HNSCC intent-to-treat (ITT) population

Landmark Progression-Free Survival (PFS) Rates

Overall Survival (OS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors

Eligibility Criteria

Inclusion Criteria: * Histologically or cytologically documented locally advanced squamous cell carcinoma of the oropharynx, hypopharynx, oral cavity, or larynx with no evidence of metastatic disease (i.e. M0). * Confirmed unresected Stage III, Stage IVA or IVB according to the eighth edition of the American Joint Committee on Cancer (AJCC) staging manual (tumor, node, metastasis (TNM) staging system). * Participants will have completed definitive concurrent chemoradiotherapy (cCRT) with curative intent prior to randomization. Exclusion Criteria: * Histologically/cytologically confirmed head and neck cancer of any other primary anatomic location in the head and neck not specified in the inclusion criteria including participants with squamous cell carcinoma of unknown primary or non-squamous histologies (eg, nasopharynx or salivary gland). Participants with \>1 primary tumors are not eligible for the study. * Participants with any of the following: 1. LA-HNSCC that was resected be…

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✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov